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Science Policy Issues and Guidance Documents

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

EPA worked with the Tolerance Reassessment Advisory Committee (TRAC) to identify science policy issues that are key to the implementation of the Food Quality Protection Act (FQPA) and tolerance reassessment. Although EPA has sought independent review and public participation on a wide variety of issues, the Agency agreed that the implementation process would benefit from a more thorough process of public notice and comment. In an October 29, 1998 Federal Register Notice, EPA published a framework to describe these issues. The papers associated with each issue are listed below. Planned papers are shown in gray.

1. FQPA 10-Fold Safety Factor
2. Dietary Exposure and Risk Assessment
3. Threshold of Regulation
4. Drinking Water Exposure
5. Residential Exposure
6. Aggregating Exposure and Risk Assessment
7. Cumulative Risk Assessment for Pesticides with a Common Mechanism of Toxicity
8. Cholinesterase Inhibition End Point
9. Use and Usage Information

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FQPA 10-Fold Safety Factor	Federal Register Notice of Availability
Standard Operating Procedures (SOPs) for Use of the FQPA Factor (PDF) (6 pp, 17KB) - April 6, 1998 Draft Toxicology Data Requirements For Assessing Risks of Pesticide Exposure to Children's Health (PDF) (6 pp, 17KB) - April 28, 1999 Draft Exposure Data Requirements For Assessing Risks of Pesticide Exposure to Children (PDF) (65 pp, 196KB) - March 8, 1999	OPP-00610 - Septemter 7, 1999
Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment (PDF) (74 pp, 257KB) - February 28, 2002 Response to Public Comments (PDF) (178 pp, 741KB) - February 28, 2002	OPP-00757 - February 28, 2002
Dietary Exposure and Risk Assessment
Guidance for the Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticisurde Programs (PDF) (28 pp, 83KB) - November 4, 1998 Guidance for Submission of Probabilistic Human Health Exposure Assessments Science Policy; Notice of Withdrawal - July 15, 2009 Guidance for Submission of Probabilistic Exposure Assessments to the Office of Pesticide Programs (Appendix) (PDF) (52 pp, 405KB) - November 4, 1998 Guidance for Submission of Probabilistic Human Health Exposure Assessments Science Policy; Notice of Withdrawal - July 15, 2009	OPP-00559 - November 5, 1998
Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern (PDF) (39 pp, 154KB) - March 16, 2000 Response to Public Comments (PDF) (83 pp, 270KB) - March 16, 2000	OPP-00593A - March 22, 2000
Use of the Pesticide Data Program (PDP) in Acute Dietary Assessment (PDF) (18 pp, 107KB) - May 26, 1999 EPA announces the withdrawal of the pesticide science policy document “Use of the Pesticide Data Program (PDP) in Acute Risk Assessment.” - September 29, 2010	OPP-00600 - May 26, 1999
Available EPA Information on Assessing Exposure to Pesticides in Food--A User's Guide (PDF) (50 pp, 510KB) (Revised) - June 21, 2000	OPP-00576A - July 12, 2000
Data for Refining Anticipated Residue Estimates Used in Acute Dietary Probabilistic Risk Assessments (Revised) - June 15, 2000 Guidelines for the Conduct of Bridging Studies for Use in Probabilistic Risk Assessment - June 23, 2000 Guidelines for the Conduct of Residue Decline Studies for Use in Probabilistic Risk Assessment - June 23, 2000	OPP-00591A - June 23, 2000
Threshold of Regulation
Assigning Values to Nondetected/Nonquantified Pesticide Residues in Human Health Dietary Exposure Assessments (PDF) (33 pp, 121K) - March 23, 2000 Response to Public Comments (PDF) (27 pp, 98K) - March 23, 2000	OPP-00570A - March 31, 2000
Threshold of Regulation Policy - Deciding Whether a Pesticide With a Food Use Pattern Needs a Tolerance (PDF) (40 pp, 110KB) - October 18, 1999 Agency responses to public comment on the “Proposed Threshold of Regulation When a Food Use Does Not Require a Tolerance (27 pp, 73K)	OPP-00569B - October 27, 1999
Drinking Water Exposure
Estimating the Drinking Water Component of a Dietary Exposure Assessment PDF (Revised) (44 pp, 144 KB) - November 2, 1999 Estimating the Drinking Water Component of a Dietary Exposure Assessment; Science Policy, Notice of Withdrawal - September 23, 2009	OPP-00577A - November 10, 1999
Drinking Water Screening Level Assessment PDF (30 pp, 7.8MB) - September 1, 2000 Standard Operating Procedure for Incorporating Screening-Level Estimates of Drinking Water Exposure in Aggregate Risk Assessments PDF (31 pp, 133KB) - September 1, 2000	OPP-00679 - October 11, 2000
Quantitative Assessment of Uses of Concern for Drinking Water	To be determined
Water Treatment Effects on Pesticide Removal and Transformation (PDF)	OPP-00731 - November 21, 2001
Residential Exposure
Standard Operating Procedures (SOPs) for Residential Exposure Assessment( (PDF) (137 pp, 927KB) - December 19, 1997 Overview of Issues Related to the Standard Operating Procedure for Residential Exposure Assessment (PDF) (119 pp, 357KB) - September 21, 1999 Framework for Assessing Non-occupational / Non-dietary (Residential) Exposure to Pesticides (PDF) (10 pp, 85KB) - December 22, 1998	OPP-00578 OPP-00579
Aggregating Exposure and Risk Assessment
General Principles for Performing Aggregate Exposure and Risk Assessments (PDF) (Revised) (79 pp, 427 KB) - November 28, 2001	OPP-00732
Cumulative Risk Assessment for Pesticides with a Common Mechanism of Toxicity
Guidance for Identifying Pesticide Chemicals and Other Substances That Have a Common Mechanism of Toxicity (PDF) (Revised) - January 29, 1999	OPP-00542 - February 5, 1999
Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity PDF (90 pp, 557KB) - January 14, 2002	OPP-00658B - January 16, 2002
Application of the 10X Safety Factor in Cumulative Risk Assessment (PDF) (17 pp, 179 KB)	OPP-00759 - February 28, 2002
Cholinesterase Inhibition End Point
The Use of Data on Cholinesterase Inhibition for Risk Assessments of Organophosphorous and Carbamate Pesticides (PDF) (53 pp, 101KB) - August 18, 2000 Docket Index	OPP-00560A - September 8, 2000
Use and Usage Information
The Role of Use-Related Information in Pesticide Risk Assessment and Risk Management PDF (Revised) (59 pp, 215 KB ) - August 21, 2000	OPP-00609A - October 11, 2000

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